Effect of probiotics in acute childhood diarrhea
| ISRCTN | ISRCTN30646529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30646529 |
| ClinicalTrials.gov number | NCT00463190 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/04/2008
- Registration date
- 01/05/2008
- Last edited
- 31/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Chien-Chang Chen
Scientific
Scientific
5, Fu-Hsing Street
Kwei-Shan
Taoyuan
333
Taiwan
Study information
| Study design | Randomised, double-blind (subject, caregiver, investigator), placebo-controlled, parallel-assignment, safety/efficacy, single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Effect of probiotics (Bio-Three®) in children's enterocolitis |
| Study objectives | Probiotics have been shown to be effective in the treatment of these conditions. There are many mechanisms by which probiotics enhance intestinal health, including stimulation of immunity, competition for limited nutrients, inhibition of epithelial and mucosal adherence, inhibition of epithelial invasion and production of antimicrobial substances. Hypothesis: Probiotics medication (Bio-Three®) could inhibit gastrointestinal infection and reduce its inflammatory response in the intestine. We plan to explore the bacterial count (microbiology) and subsequent immune response in probiotic inhibition of enterocolitis in children. |
| Ethics approval(s) | Institutional Review Board of Chang Gung Memorial Hospital, Taoyuan, Taiwan. Date of approval: 10/01/2006 |
| Health condition(s) or problem(s) studied | Enterocolitis |
| Intervention | Treatment group: Oral probiotics (Bio-Three®) 3 times daily for 7 days Control group: Placebo 3 times daily for 7 days Bio-three® contains a mixture of Bacillus mesentericus, Streptococcus faecalis and Clostridium butyricium. Total bacterial count: 1.5 x 10^8 colony forming units (cfu) per tablet. |
| Intervention type | Other |
| Primary outcome measure | To determine whether probiotics medication Bio-Three® inhibits gastrointestinal infection and reduce its inflammatory response in the intestine. The following were assessed: 1. Clinical symptoms 2 days after medication 2. Microbiology study 3 days and one week after medication The time and the consistency of every stool were recorded and the total hospital duration was calculated. Severity of diarrhoea was evaluated according to the following parameters: number of stools, fecal consistency, the presence or absence of mucus, and blood in stools. |
| Secondary outcome measures | Other clinical symptoms/signs including fever, vomiting, dehydration, abdominal pain, bloating, daily dietary intake and appetite were also recorded for 7 to 10 days. |
| Overall study start date | 01/02/2006 |
| Completion date | 30/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Age: From 3 months to 12 years, both male and female children 2. Clinical symptom of diarrhoea less than 3 days |
| Key exclusion criteria | 1. Severe abdominal distension with risk of bowel perforation 2. Risk of sepsis 3. Past history of surgical operation of gastrointestinal tracts |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 30/11/2007 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
5, Fu-Hsing Street
Taoyuan
333
Taiwan
333
Taiwan
Sponsor information
Maywufa Company Ltd (Taiwan)
Industry
Industry
5F, 167, Fu-Hsing North Road
Taipei
105
Taiwan
"ROR" |
https://ror.org/01m15jk16 |
|---|
Funders
Funder type
Industry
Chang Gung Memorial Hospital (Taiwan)
No information available
Maywufa Company Ltd (Taiwan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2010 | 31/01/2019 | Yes | No |
Editorial Notes
31/01/2019: Publication reference added
